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NCT04177303WithdrawnPhase 3

Incretin Hormones in Type 1 Diabetes Mellitus;Effect of Metformin Treatment

Gut-derived Incretin Hormones in the Pathophysiology of Type 1 Diabetes Mellitus; Effect of Metformin Treatment

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

Investigators aim is to conduct an RCT to study the effect of adjunct metformin treatment to insulin monotherapy in patients with type 1 diabetes, targeting the intestinal incretin secretion. The patients will be randomly allocated to metformin or placebo treatment for 4 months

Status (registry)
Withdrawn
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
0 (actual)
First submitted
30 Oct 2019
Start date
29 Nov 2019
Primary completion date
31 Dec 2024
Lead sponsor
Hellenic Institute for the Study of Sepsis
NCT number
NCT04177303

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior diagnosis of cancer within 2 years

Other illness

  • Any cardiovascular disease within the last 3 months
  • NYHA stage 3 or 4 heart failure
  • Uncontrolled angina
  • Gastrointestinal disease or gastroparesis
  • Untreated or uncontrolled thyroid disease

Lab values

  • Liver failure [AST>135 IU/L or ALT>129IU/L (3 x the upper normal limit)] • Kidney failure or GFR<60 ml/min/1.73m2
  • Other medication that affect glucose metabolism within the last 3 months (metformin, SGLT2, GLP-1 analogues, amylin analogues, systemic glucocorticosteroids)

Other

  • Pregnancy or breastfeeding
  • Alcohol consumption > 2-drinks per day or other substance abuse

Who the study is looking for

  • Age ≥ 18 years
  • T1DM (Diagnosis of diabetes before the age of 35 years and insulin use within 1 year of diagnosis)
  • Treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.

Incretin Hormones in Type 1 Diabetes Mellitus;Effect of Metformin Treatment (NCT04177303) – Frontlight Research